510(k) Report

FDA applicant

Helax AB

Uppsala, SE3 decisions1997–19990 recalls

FDA records 3 decisions for Helax AB (Uppsala, SE) from 1997 to 1999: 3 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and KPQ (System, Simulation, Radiation Therapy). Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Helax AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Helax AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Helax AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MUJSystem, Planning, Radiation Therapy Treatment1decision
  • KPQSystem, Simulation, Radiation Therapy1decision
  • IYEAccelerator, Linear, Medical1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K993766Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 19991cites it
  • K972617Helax-VisirHelax AB · 19971cites it

What has FDA decided for it lately?

  • K993766Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999
  • K982857Helax-Imcon, Version 1.0Helax AB · 1998
  • K972617Helax-VisirHelax AB · 1997

All 3 as Helax AB →